Helicobacter pylori Diagnostic Testing Accuracy in a High-Prevalence Native American Population of Northern Arizona.

Helicobacter pylori (H. pylori) is a common gastric pathogen and a leading cause of non-cardia gastric cancers. Known determinants can affect the diagnostic accuracy of invasive clinical methods for H. pylori diagnosis. The objective of this study was to determine the diagnostic accuracy of the CLOtest, a rapid urease test, and the histopathologic examination compared with polymerase chain reaction (PCR) in esophagogastroduodenoscopy patients from a population with high prevalence and other risk factors that may influence diagnostic accuracy. From 2018 to 2022, patients were recruited from a medical care center serving the southwestern Navajo Nation. Summary statistics were calculated using PCR as the comparator to the CLOtest and histopathologic examination. Among the 466 study participants, 27.1% (95% CI 22.9, 31.7%) tested positive for H. pylori using PCR to detect pathogen DNA. Sensitivity was lowest for the CLOtest (57.0%; 95% CI 45.8, 67.6) and highest for the combination the CLOtest and histopathology (72.2%; 95% CI 62.8, 80.4). Patient history of infection or possible GI bleeding influenced sensitivity by over 5%. In high H. pylori prevalence areas, emphasis should be placed on ensuring adequate treatment of suspected positive infections as false-positive results were rare. Including a more sensitive test might reduce the number of individuals falsely classified as H. pylori negative.